Brazil Submissions

Brazil Submissions : Brazil is the largest pharmaceutical market in Latin America and ranks sixth globally, making entry into this market a strategic priority. However, Brazil’s national regulatory authority — the Agência Nacional de Vigilância Sanitária (ANVISA) — maintains a strict and technically complex approval process. In this guide, we break down how to successfully register your drug with ANVISA,

  1. Drug Categories and Initial Requirements

    2. ANVISA classifies drugs into categories such as new drugs, generics, branded generics (similar medicines), herbal, biologicals, OTCs, and radiopharmaceuticals. Each has its own set of regulatory and data requirements.

    • Before initiating the submission, companies must:
    • Identify the correct classification for their product.
    • Designate a local Brazilian legal representative, who is responsible for registration, importation, and regulatory communication.
    • Verify reference drugs for generic and similar submissions to ensure pharmaceutical equivalence.
    Getting these steps right early will prevent costly rework and delays.

  1. CTD Format: Brazil’s Regulatory Standard

    2. Since 2019, ANVISA has adopted the international Common Technical Document (CTD) format, structured into:
    • Module 1: Regional administrative information (licenses, powers of attorney, product labeling in Portuguese).
    • Modules 2 to 5: Quality (CMC), non-clinical, and clinical data per ICH M4.

    In 2024, ANVISA confirmed that all new and variation filings must be submitted electronically, with a declaration that the complete CTD will be submitted via USB or physical media (“Aditamento – Formato CTD”). This hybrid model remains valid until April 30, 2025, after which full electronic submission is expected to be mandatory.

  1. Regulatory Filing Process Step-by-Step

      2. (i)Dossier Preparation

      Key sections include:

      • Module 1: Power of attorney, GMP certificates, Certificate of Pharmaceutical Product (CPP), local labeling, safety data, and international regulatory status.
      • Module 2: Executive summaries of quality, safety, and efficacy.
      • Module 3: Comprehensive quality data (drug substance, manufacturing, specifications, stability).
      • Modules 4 & 5: Non-clinical (toxicology) and clinical (bioequivalence, PK, efficacy) studies.

      Brazil requires Zone IVB stability studies (hot/humid climate): minimum 6 months accelerated + 6 months long-term to justify a 24-month shelf life. Forced degradation studies (FDS) are also mandatory.

      (ii)Submission and Protocol
      • An initial electronic petition is submitted through ANVISA’s portal, accompanied by a declaration about submitting the full CTD in physical format.
      • The CTD Aditamento (full technical file) is delivered manually to ANVISA via USB or DVD.
      (iii)Technical Review

      ANVISA reviews the submission and may issue a deficiency letter (DQR). Target timelines are:

      • New drug: 120 days
      • Post-approval changes: 60 days
      • Priority reviews: 45 days

      The review clock pauses until the applicant responds to queries.

      (iv)GMP Inspections
      • ANVISA may inspect API and FDF manufacturing sites. These usually happen within 6 months post-submission, and GMP certificates are issued in 45–60 days.
      (v)Local Testing
      • Samples may be requested for testing in accredited Brazilian labs to ensure compliance with submitted specs.
      (vi)Registration Approval
      • Once the technical review, GMP inspection, and sample testing are complete, ANVISA grants market authorization, valid for 10 years.
      • Renewals must be submitted 6 months before expiration.

      Any changes (site, composition, packaging) require post-approval filings known as “secondary petitions” with defined review timelines.

      How Masuu Can Help You

      Masuu Pharma Quality and Regulatory Consultants offers end-to-end support for Brazilian regulatory filings(Brazil Submissions). Our services include:
      • Gap Analysis: We evaluate your dossier and processes against ANVISA’s expectations for CTD, GMP, and stability.
      • CTD Preparation: We prepare and format Modules 1–5, ensuring accuracy, compliance, and smooth navigation through the e-submission process.
      • Stability Strategy & FDS: We design and support studies compliant with Zone IVB and forced degradation requirements.
      • Submission Management: We handle hybrid protocol logistics, from electronic petitions to physical media delivery.
      • GMP Audit Readiness: We offer mock inspections, training, and remediation strategies to prepare for ANVISA site audits.
      • Regulatory Interactions: We prepare response packages for DQRs and guide your communication with ANVISA.
      • Post-approval Services: We manage renewals, label updates, and change control (post-approval variations).
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